Regulatory Strategy

Achieving Regulatory Milestones

Having a well-constructed regulatory submission strategy that is interwoven into a sponsor’s operational program is even more critical to achieving success than in the past. Between the escalating competition, speed, cost, and risk; benefit pressures on sponsors; the need for payers to see ‘best-in-value’ data of a drug to justify adding it to the formulary; new global regulatory expectations for electronic submissions; or the complexity of the drug itself—strategy is key.

With more than 30 years of experience and a team of 200 scientific regulatory professionals working with sponsors to achieve global regulatory milestones, Synchrogenix focuses on the strategy first, and then maps an efficient and effective operational plan. By involving us as a strategic partner—as early as identification of a lead candidate through life cycle management—we ask the right questions during front end meetings, and working together with our Certara colleagues, assess the right processes, tools, and resources to achieve all goals.

We support the full range of regulatory programs, working alongside sponsors, including:

  • Preparation for agency meetings, including pre-IND, end of Phase 2, pre-NDA, and health authority advisory committee meetings
  • FDA submittals: IND, NDA/BLA, ANDA, 505b, orphan drug, and pediatric study plan (PSP)
  • Global health authority submittals: EMEA, PMDA, pediatric investigational plan (PIP), HTA, etc.
  • Initial, follow-on, and repurposed drug applications

Synchrogenix – Delivering RS3

As industry leaders, Synchrogenix and Certara can navigate the global drug development maze to increase access to treatments, optimize business outcomes, and address the needs of all stakeholders by providing RS3:

Strategy – global regulatory leadership, critical path optimization, public transparency exposure, peer review, agency interactions, target product profile identification, clinical development, formulation, probability of success and risk mitigation
Science – clinical and non-clinical, toxicology and chemistry, regulatory communications, drug safety, risk minimization, clinical pharmacology, pharmacometrics, biostatistics, proof of concept
Services – authorship, regulatory operations, quality control, transparency and disclosure solutions, tech-enabled services

Our services span to meet the needs of the virtual biopharma space all the way to the global pharmaceutical industry. Our unique expertise covers novel therapies, innovative approval pathways, rare and orphan indications, publications planning, translational science, combination products, pediatric development, portfolio management and rationalization, and market access. With the variety and the breath of the needs we serve, there is a consistent challenge that all of our clients face: the challenge is simply how do we do more with less? Both Synchrogenix and Certara are leading the charge in our tech-enabled solutions, our innovative and market leading processes, knowledge, and technology to maximize the value of time and data to achieve the most valuable outcome for our clients.

Regulatory Writing Meets Model-informed Drug Development

While model-informed drug development (MIDD) is increasingly being requested by global regulators, articulating this approach is both an art and a science. It starts with asking the right questions, creating the justification based on pre-clinical data and the strength of the model, and culminates in regulatory approval. In addition, successfully employing MIDD requires addressing specific challenges in each therapeutic area while satisfying the sponsor’s overall business objectives and constraints. Meeting these challenges requires strategic regulatory direction and writing, a thorough understanding of modeling and simulation, as well as traditional clinical development, and an understanding of the program’s constraints and the regulators’ current positions.

Synchrogenix is the regulatory writing and communications arm of Certara and, therefore, is uniquely qualified to articulate how MIDD has been used in a program and the benefits it has provided along the continuum. And as the science of MIDD is continuously evolving, Certara and Synchrogenix will be leading both its application and articulation to increase the probability of success at each milestone.

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